Aging Clinical Trial
Official title:
Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness
With increasing age and health issues associated with aging, many systemic cellular and
structural changes are known to occur. The intent of this trial is to determine the safety
and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve
the quality of life and functional health.
Isolation and concentration of cSVF will be documented.
To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and
stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic
digestion to isolate and concentrate these cells, is followed with returning these cSVF
elements only via 500 cc Normal Saline delivered via peripheral vein (IV).
Documentation of cellular numbers and flow cytometer viability testing is to be correlated
with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form
tracking
With increasing age and health issues associated with aging, many systemic cellular and
structural changes are known to occur. The intent of this trial is to determine the safety
and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve
the quality of life and functional health.
Isolation and concentration of cSVF will be documented.
To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and
stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic
digestion to isolate and concentrate these cells, is followed with returning these cSVF
elements only via 500 cc Normal Saline delivered via peripheral vein (IV).
Documentation of cellular numbers and flow cytometer viability testing is to be correlated
with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form
tracking.
Safety of use of certain allogeneic human mesenchymal stem cells (hMSC) has been tested and
established along with the effectiveness of use. Autologous stem-stromal cells have been
proven safe and effective in many applications and in clinical trials currently underway.
These cells are easily obtained and isolated/concentrated in a closed system from patient's
adipose derived stromal vascular fraction (cSVF). This is important as such tissues are
uniquely the patient's cells, without the need for culture expansion of non-self human
tissues, therefore potentially increasing availability to obtain non-allergenic, autologous
cells known to be multipotent (can form a variety of specialized cell populations from the
body) cell group within the cellular stromal vascular fraction (cSVF) present in essentially
all tissues throughout the body (muscle, brain, bone, cartilage, nerve, skin, cardiac muscle,
etc.).
This study seeks to determine the safety, efficiency, and in subsequent studies (phase III
type) to determine optimal dosages that are needed. Delivery of the cSVF will be returned to
the patient's via a standard Normal Saline intravenous infusion (IV).
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